Recall Z-1577-2013— Becton Dickinson & Company

Name: FDA recall Z-1577-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-01

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2013-05-01, terminated 2013-09-25. It names one FDA 510(k) clearance: K992734. Product: BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications.. Reason: There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2013-05-01
Terminated: 2013-09-25
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K992734 — BECTON DICKINSON SYRINGEBd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1999-10-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications.

Reason for recall

There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe.

Data sourced from openFDA. This site is unofficial and independent of the FDA.